Index of drugs

4 mg / ml. In clinical situations requiring glucocorticoid therapy to treat and / or relieve symptoms of the underlying disease. Treatment of acute life-threatening conditions requiring glucocorticosteroids (eg shock, brain edema, asthmatic condition).8 mg / ml. Treatment of acute life-threatening conditions requiring glucocorticoid therapy.

1 ml of solution contains 4 mg Dexamethasone phosphate in the form of sodium salt (and sodium edetate, propylene glycol, sodium chloride, sodium hydroxide) or 8 mg dexamethasone phosphate in the form of sodium salt (and sodium edetate, propylene glycol, sodium hydroxide).

Fluorored glucocorticosteroid with strong antiallergic, anti-inflammatory and membrane stabilizing properties. It works 7.5 times more strongly than Prednisolone and prednisone and 30 times more potent than hydrocortisone. Practically no mineralocorticoid activity. The biological effect of glucocorticoids is associated with the activation of transcription of corticosteroid-dependent genes. Anti-inflammatory, immunosuppressive and anti-proliferative effects are caused by various factors, including reduced formation, release and activity of inflammatory mediators and by inhibition of the function and migration of specific inflammatory cells. In addition, the effect of sensitizing T lymphocytes and macrophages on target cells is probably inhibited by glucocorticoids. The drug also affects the metabolism of carbohydrates, proteins and lipids. Dexamethasone is bound to albumin depending on the dose. When very high doses are administered, the larger fraction circulates in free form in the blood. In the case of hypoalbuminemia, the fraction of unbound (active) glucocorticosteroid increases. Because of the biological T_0,5 > 36 h, dexamethasone is included in the group of long-acting glucocorticoids. Medium T_0,5 dexamethasone (in plasma) in the elimination phase in adults is approx. 250 min (± 80 min). Dexamethasone is largely excreted via the kidneys in free form. It is partially metabolised and the metabolites are mainly excreted by the kidneys in the form of glucuronides or sulphates. Damage of renal function does not significantly affect the secretion of Dexamethasone, whereas T_0,5 in the elimination phase is prolonged in patients with severe liver disease.

In ACUTE, life-threatening conditions, there are no contraindications, especially if the drug is expected to be used for a short time (24-36 h). Hypersensitivity to the active substance or to any of the excipients. Systemic infection unless anti-infective therapy is used. Intramuscular injection should not be used in patients with ITP.In addition, for a 4 mg / ml dose. Intra-articular injection is contraindicated in the following cases: infection within or in the immediate vicinity of the joint requiring treatment; bacterial arthritis; instability of the joints requiring treatment; hemorrhagic diathesis (spontaneous or caused by anticoagulants); periarticular calcifications; extravascular bone necrosis; rupture of the tendon; Charcot's pond. The infusion administration without additional causal treatment is contraindicated in the presence of infections at the injection site.

During treatment with high doses, monitoring of water and electrolyte management (risk of edema), blood pressure, heart activity (risk of arrhythmia and heart failure), blood Glucose concentration should be monitored. The patient should also be monitored for stomach and duodenal ulcers and convulsions. Patients treated with dexamethasone should be monitored for the presence of disturbing psychological symptoms, especially for the reduction of suicidal mood or thoughts. Special precautions should be taken when considering the use of glucocorticosteroids in patients with severe affective disorder currently or in history (also in a family history - first-degree relatives); account should be taken of depressive, manic-depressive illness and previous post-traumatic psychoses.Corticosteroids should not be used in patients with head trauma or stroke, because the benefit is unlikely to be beneficial or even harmful. Particularly cautiously used in patients with: osteoporosis (a special risk in postmenopausal women); hypertension or congestive heart failure; severe mental illness (especially posteroidal) now or in an interview; diabetes (or a history of diabetes); tuberculosis in history (risk of relapse); glaucoma (or glaucoma in a family history); myopathy caused by a corticosteroid in a history; liver failure; renal failure; epilepsy; ulceration of the stomach and intestines; migraine; some parasitic diseases, especially amebosis; inhibition of growth due to accelerated root closure resulting from long-term glucocorticoid therapy; Cushing's syndrome; in elderly patients (increased risk of side effects that may be more severe, especially osteoporosis, hypertension, hypokalemia, diabetes, susceptibility to infection and thinning of the skin); in infants, children and adolescents (the risk of stunting, depending on the dose, this effect may be irreversible). Available data indicate the occurrence of long-term adverse events affecting the neurological development of preterm infants with chronic lung disease after initiation of early dexamethasone treatment (<96 h) at an initial dose of 0.25 mg / kg. 2 times a day. Glucocorticoids may mask the symptoms of infection or inflammation and impair the body's defenses and increase the susceptibility to infections and their severity, infections may be more severe (eg chickenpox and measles may even lead to death). Patients who have not previously had these diseases should avoid exposure. Patients on glucocorticoids at the time of exposure or who used them during the last 3 months within 10 days after exposure to chickenpox should be given prophylactic immunoglobulinvaricella zoster (VZIG). In the case of the development of chickenpox, the patient requires appropriate specialist treatment. Do not stop treatment with glucocorticosteroids, but you may need to increase the dose you have been using. After exposure to measles, prophylactic administration of immunoglobulin (IG) is indicated. Adequate anti-infective therapy should be accompanied by glucocorticotherapy, if necessary, for example in tuberculosis, viral and fungal eye infection. Live vaccines should not be used in people with impaired immune responses. The antibody response to other vaccines may be reduced. When topical (for 4 mg / ml), the possibility of side effects and interactions should be taken into account as with the general administration. Intra-articular administration of glucocorticoids increases the risk of joint infections. Prolonged and repeated use of glucocorticosteroids in loaded joints may lead to deterioration of degenerative joint changes. One possible reason is overloading the affected joint after the pain or other symptoms have subsided. Caution should be exercised when injecting into the space between the tendon sheath and tendon in the treatment of conditions such as tendinitis or tendon sheath, because cases of tendon rupture have been reported. Adverse drug reactions can be minimized by using the lowest effective dose for the shortest period and by using the required daily dose as a single dose given in the morning or if possible as a morning dose every other day. Frequent monitoring of the patient's clinical condition is necessary to select the appropriate dose. Following parenteral glucocorticoid administration, severe anaphylactoid reactions (such as glottis, swallow, bronchospasm) may occur, particularly in patients with a history of allergy. If anaphylactoid reactions occur, the following measures are recommended: immediate slow intravenous injection of 0.1-0.5 ml of epinephrine, intravenous aminophylline and artificial respiration, if necessary. Long-term glucocorticosteroids should be discontinued gradually to avoid the occurrence of acute adrenal insufficiency; The dose should be reduced over several weeks or months, depending on the dose and duration of treatment.In patients who received a higher than physiological dose (approximately 1 mg dexamethasone) for more than 3 weeks, the drug should not be discontinued suddenly; the method of dose reduction should be largely dependent on the likelihood of relapse; during the withdrawal period clinical evaluation of the patient's condition is necessary; if the probability of recurrence is low, but there are doubts about suppression of the hypothalamic-pituitary-adrenal axis, the dose used may be immediately reduced to a physiological dose, further dose reduction should be slower. Abrupt discontinuation of systemic glucocorticoid therapy, which lasted up to 3 weeks, is appropriate if the relapse is unlikely. Abrupt discontinuation with dexamethasone <6 mg / day for 3 weeks probably will not lead to clinically significant suppression of the hypothalamic-pituitary-adrenal axis in most patients. In the case of nw. groups of patients should be considered for gradual withdrawal of dexamethasone, even if used less than 3 weeks: patients who previously used glucocorticoids, especially for more than 3 weeks; patients who have been prescribed a short-term treatment within one year of the end of long-term treatment (months or years); patients who have risk factors for adrenal insufficiency other than glucocorticoid therapy; patients receiving dexamethasone> 6 mg / day; patients repeatedly taking doses of the drug in the evening. Co-morbidities, trauma or surgery in the case of long-term treatment may require a temporary dose increase. If discontinuation of glucocorticosteroids occurs after long-term therapy, periodic re-admission may be necessary. Due to the propylene glycol content, the drug may cause skin irritation. The medicine contains less than 1 mmol (23 mg) sodium per ampoule, that is, it is "sodium-free".

Dexamethasone readily crosses the placenta - in pregnancy it can only be used if the benefit to the mother outweighs the potential risk to the fetus. Prolonged or frequent administration of corticosteroids during pregnancy may increase the risk of delaying fetal development. In children of mothers treated with corticosteroids during pregnancy theoretically, adrenal insufficiency may occur, which usually disappears after birth and is of rare clinical significance. Corticosteroids are excreted in human milk, although there is no data on dexamethasone. It is recommended to stop breastfeeding while taking high doses of dexamethasone, as the infant may experience adrenal suppression.

During treatment, the following side effects may occur, which are significantly dependent on the dose and duration of treatment (frequency can not be determined): masking of infections, occurrence or worsening of viral, fungal, bacterial, parasitic and opportunistic infections, stimulation of strongyloidosis, moderate leukocytosis, lymphopenia, eosinopenia, polycythemia, hypersensitivity reactions (eg drug eruptions), severe anaphylactic reactions (arrhythmias, bronchospasm, decrease or increase in blood pressure, circulatory collapse, cardiac arrest), weakened immune system, suppresive adrenal function and induction Cushing's syndrome (typical symptoms: lunar face, trunk obesity and excess body fluids), sodium retention (accompanied by edema formation), increased potassium excretion (risk of arrhythmia), weight gain, tolera reduction Glucose, diabetes, hypercholesterolemia, hypertriglyceridaemia, increased appetite, depression, irritability, euphoria, increased motor activity, psychosis, mania, hallucinations, mood changes, anxiety, sleep disorders, suicidal thoughts, alleged brain tumor, the appearance of hidden epilepsy, increased propensity for seizures in epilepsy with symptoms, cataract (especially posterior subcapsular), glaucoma, worsening of corneal ulcer symptoms, aggravation of viral, fungal and bacterial ocular inflammations, deterioration of bacterial keratitis, ptosis, mydriasis, conjunctival edema, iatrogenic scleral perforation in rare cases a reversible exophthalmos; hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (also as a withdrawal syndrome after long-term treatment), increased capillary fragility, stomach and intestinal ulcers,bleeding from the stomach or intestines, pancreatitis, epigastric disorders, stretch marks, atrophy of the skin, telangiectasia, petechiae, haemorrhage, hypertrichosis, steroid acne, rosacea-like skin inflammation (around the mouth), changes in skin pigmentation, myopathy, atrophy and muscle weakness, osteoporosis (dose-dependent, also possible during short-term use), sterile osteonecrosis, tendon disorders, tendinitis, tendon rupture, epidural mortality, growth inhibition in children, sex hormone secretion disorders (resulting in the appearance of irregular menstrual bleeding , including lack of menstrual bleeding, hirsutism, impotence), delayed wound healing. After topical administration (for a 4 mg / ml dose): local irritation and intolerance (feeling hot, prolonged pain); disappearance of the skin and subcutaneous tissue at the injection site, if the corticosteroids are not injected into the joint cavity.

Doses are determined individually depending on the patient's clinical condition, severity of the disease and response to treatment. The duration of treatment depends on the indications. In special cases, a higher dose of dexamethasone may be required. If no positive response to treatment occurs within a few days, corticosteroids should be discontinued.General dosage guidelines: 4-16 mg / day, exceptionally up to 32 mg / day. Usually a single dose is 4-8 mg; this dose can be repeated if necessary at appropriate intervals several times a day. In emergency situations that are life threatening (eg anaphylactic shock, acute asthma attack), much higher doses may be needed. When the disease is under control, the dosage should be gradually reduced to the lowest effective dose by monitoring the patient's condition. Topical injection and infusion therapy usually require a dose of 4-8 mg; a dose of 2 mg is sufficient when injected into small joints.Special groups patients. In the case of hypothyroidism or cirrhosis, relatively small doses may be sufficient or a dose reduction may be required. Elderly use does not require special dosing.Children: the dosage requirements are variable and can be changed depending on the individual needs of the patient; usually 0.2-0.4 mg / kg / day.Way of giving. intravenous: slow injection, lasting a few minutes (rapid intravenous injection of high doses of glucocorticoids may sometimes cause cardiovascular collapse, should not be used) or infusion (immediately prior to infusion, the contents of the ampoule are diluted in isotonic sodium chloride solution or 5% solution glucose).intramuscular: in the absence of intravenous use; intramuscular administration should be deep, to a large muscle mass.intraarticular (4 mg / ml): only under sterile conditions. A single intra-articular injection is generally sufficient to effectively relieve symptoms. If the Next injection is necessary, do not administer it for at least the next 3-4 weeks. The number of injections into one joint should be limited to 3-4 times. The medical examination of the joints is recommended, especially after repeated injections.locally the (4 mg / ml): only under sterile conditions; in the areas with the most intense pain or around the tendons of the tendons. Do not inject into the tendon. Avoid injections at short intervals.